AQUA Laminoplasty Systems— 510(k) K252930

Name: FDA 510(k) clearance K252930
Creator: U.S. Food and Drug Administration
Published: 2026-05-27

Substantially Equivalent

ZheJiang Decans Medical Devices Co., Ltd.

FDA 510(k) clearance K252930 for AQUA Laminoplasty Systems, Substantially Equivalent on 2026-05-27. Applicant: ZheJiang Decans Medical Devices Co., Ltd.. Device class: 2.

Summary

ZheJiang Decans Medical Devices' AQUA Laminoplasty Systems are filed under NQW, metal laminoplasty spinal plate orthoses.

Class II, 21 CFR 888.3050. Orthopedic is both the classification panel and the review panel, and it was a Traditional 510(k).

Decans filed from Jiaxing, China. Review took 254 calendar days (September 15, 2025 to May 27, 2026).

Clearance details

Applicant: ZheJiang Decans Medical Devices Co., Ltd.
Product code: Product code NQW
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2025-09-15
Decision date: 2026-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jiaxing, CN

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.